MAUDE Adverse Event Report: ETHICON INC. LAPRA-TY ABSORBABLE X6::SUTURE CLIP; CLIP, IMPLANTABLE

Model Number XC200

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and clips suture were used.During the procedure, the clip misaligned.Another device was used to complete the case.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The following information was requested, but unavailable: it was reported the clip misaligned, please provide more details: if we get the information, the pc will be updated.Package lot number of the clips? ditto.Please provide the applier product code and lot number? ditto.Please confirm if there is an issue with the applier? if yes, please create a product complaint and provide the respective reference number(s).Ditto.Please explain how the clips were loading into the applier? ditto.Please confirm if the jaws of the applier are at 90 degree to the surface of the clip cartridge when loading? ditto.Was the applier checked for damaged (jaws straight and aligned)? ditto.When the event occurred, was the suture placed near the hinge of the clip? ditto.Were you able to lock the clip closed on the suture? if yes, after it closed, was the clip holding securely fixed on the suture? ditto.If the clip did not close/hold on the suture, was the clip used in an application where the suture was under tension? ditto.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample determined that the xc200 reload was received outside of its package and no packaging was returned for analysis.5 clips were returned inside of the reload incorrectly positioned and taped, upon visual inspection, one clip was found to be damaged as if it has burn marks.The remaining 4 clips were manually loaded and tested for functionality with a test device.Upon functional testing of the clips, the instrument loaded, retained, and deployed 4 clips as intended over the suture.The 4 clips were fully functional and conforming.The event reported was confirmed and it is related to improper use of the device.Grasp the applier by the handle and insert the jaws of the instrument into the individual cartridge slot.Ensure the tips of the applier are perpendicular to the surface of the cartridge.Insert the applier until it stops.Do not force the applier.It should enter and withdraw from the cartridge smoothly.Withdraw the applier from the cartridge.The clip will be securely held in the applier jaws.Place a suture clip approximately 5 mm from the cut end of the suture.Under endoscopic visualization, the suture is placed within the jaws of the loaded clip away from the latch area.Position the clip by sliding it down the suture until it makes contact with the tissue.Note: excessive tension may cause suture and clip to pull through tissue or may cause clip slippage.The applier jaws are closed by squeezing the handle of the applier until the clip is visibly locked.In all cases, the surgeon should verify closure and security.Please reference the instruction for use for more information.As part of quality process all devices are manufactured, inspected, and released to approved specifications.No lot or batch were provided, batch history records (bhr) could not be performed.As part of our quality process, the manufacturing records of this lot could not be completed as the lot number was not provided.

• Brand Name: LAPRA-TY ABSORBABLE X6::SUTURE CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16014730
• MDR Text Key: 308373896
• Report Number: 2210968-2022-10457
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K931492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XC200
• Device Catalogue Number: XC200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2022
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1